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Test ID: 80027
B-Cell Lymphoma, FISH, Tissue

Secondary ID A test code used for billing and in test definitions created prior to November 2011

80027

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with various B-cell lymphomas

 

Tracking known chromosome abnormalities and response to therapy in patients with B-cell neoplasms

Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
19169One Additional FISH ProbeNoNo
19170Two Additional FISH ProbesNoNo
19171Four Additional FISH ProbesNoNo
19432Three Additional FISH ProbesNoNo
19433Five Additional FISH ProbesNoNo
19434Six Additional FISH ProbesNoNo
19435Seven Additional FISH ProbesNoNo
19436Eight Additional FISH ProbesNoNo
19437Nine Additional FISH ProbesNoNo
19438Ten Additional FISH ProbesNoNo
19439Eleven Additional FISH ProbesNoNo
19440Twelve Additional FISH ProbesNoNo
19855Thirteen Additional FISH ProbesNoNo
19856Fourteen Additional FISH ProbesNoNo
19857Fifteen Additional FISH ProbesNoNo
19858Sixteen Additional FISH ProbesNoNo
19859Seventeen Additional FISH ProbesNoNo
19860Eighteen Additional FISH ProbesNoNo
19861Nineteen Additional FISH ProbesNoNo
19862Twenty Additional FISH ProbesNoNo

Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
8874Path Consult,Lmtd w/o Review of PMRNoYes

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

The number of probes ordered will determine the price of the testing. When this test is ordered, a charge for 2 FISH probes and interpretation is included. If additional probes or the entire panel are ordered, additional probes charges will be added.

 

If the patient is being tracked for known anomalies, indicate which anomalies need to be investigated.

 

Depending on the lymphoma subtype suspected, the most appropriate probes to order are listed in the table: Common Chromosome Anomalies in B-Cell Lymphomas in Clinical Information.

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

Method Name A short description of the method used to perform the test

Fluorescence In Situ Hybridization (FISH) with DNA Probes

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

B-Cell Lymphoma, FISH, Ts

Aliases Lists additional common names for a test, as an aid in searching

BCL2
BCL6
Burkitt lymphoma
Burkitt-like lymphoma
CCND1/IGH
Diffuse large cell lymphoma
Follicular lymphoma
IGL
Lambda
MALT lymphoma
Mantle cell lymphoma
MYC/Lambda
3q27 rearrangement
8q24 rearrangement
18q21 rearrangement
t(8;14) (q24.1;q32) (MYC/IGH)
t(8;22) (q24;q11.2) (MYC/IGL)
t(11;14) (q13;q32) (CCND1/IGH)
t(11;18) (q21;q21) (BIRC3/MALT1)
t(14;18) (q32;q21) (IGH/MALT1)
t(14;18)(q32;q21) (IGH/BCL2)

Specimen Type Describes the specimen type needed for testing

Mixed

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Provide a reason for referral with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed.

 

Forms:

1. Cytogenetics Hematologic FISH Panel Patient Information Sheet (Supply T603) in Special Instructions

2. If not ordering electronically, submit a Cytogenetics Hematologic Disorders Request Form (Supply T607) with the specimen.

 

Advise Express Mail or equivalent if not on courier service.

 

Submit only 1 of the following specimens:

 

Specimen Type: Lymph node

Preferred: Tissue block

Collection Instructions: Formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Include 1 hematoxylin and eosin (H and E)-stained slide.

 

Acceptable: Slides

Collection Instructions: For each probe set ordered, 2 unstained consecutive tissue sections cut at 5 microns and placed on positively charged microscope slides. Include 1 H and E-stained slide.

                                                                                                                   

Specimen Type: Solid tumor

Preferred: Tissue block

Collection Instructions: FFPE-tumor tissue block. Include 1 H and E-stained slide.

 

Acceptable: Slides  

Collection Instructions: For each probe set ordered, 2 unstained consecutive tissue sections cut at 5 microns and placed on positively charged microscope slides. Include 1 H and E-stained slide.

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Note: No specimen should be rejected. If specimen not received at appropriate temperature, include note to laboratory. If questions, contact laboratory

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
MixedAmbient (preferred)
 Refrigerated 

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Mature B-cell lymphoma can be low grade, intermediate grade, or high grade, and the prognosis and clinical course are highly variable. Genetic abnormalities have emerged as one of the most important prognostic markers in B-cell lymphomas and can aid in diagnosis. Several chromosome anomalies and variants of these anomalies have been associated with various lymphoma subtypes (see table below). Unfortunately, conventional chromosome studies cannot be employed on paraffin-embedded tissue, and molecular genetic analyses are often problematic in the study of lymphomas. Fluorescence in situ hybridization (FISH) permits the detection of abnormal gene associated with various chromosome translocations and inversions in B-cell lymphoma (see table below).  

Common Chromosome Anomalies in B-Cell Lymphomas

Lymphoma Type

Chromosome Anomaly

FISH Probe

Burkitt (pediatric)

8q24.1 rearrangements

MYC

t(8;14)(q24.1;q32)

MYC/IGH

t(8;22)(q24.1;q11.2)

MYC/IGL

--reflex: 22q11.2 rearrangement

IGL

Mantle Cell

t(11;14)(q13;q32)

CCND1/IGH

Follicular

t(14;18)(q32;q21)

IGH/BCL2

Diffuse large B cell, Burkitt-like "double-hit"

 

3q27 rearrangements

BCL6

t(14;18)(q32;q21)

IGH/BCL2

8q24.1 rearrangements

MYC

t(8;14)(q24.1;q32)

MYC/IGH

t(8;22)(q24.1;q11.2)

MYC/IGL

--reflex: 22q11.2 rearrangement

IGL

MALT Lymphoma

t(11;18)(q21;q21)

BIRC3/MALT1

--reflex: t(14;18)(q32;q21)

 IGH/MALT1

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation Provides information to assist in interpretation of the test results

A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.

 

Detection of an abnormal clone is supportive of a diagnosis of a B-cell lymphoma. The specific anomaly detected may help subtype the neoplasm.

 

The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test is not FDA-approved and it is best used as an adjunct to existing clinical and pathologic information.

 

Fixatives other than formalin (eg, Prefer, Bouin) may not be successful for FISH assays.  

 

Although FISH testing will not be rejected due to nonformalin fixation, results may be compromised.

 

Paraffin-embedded tissues that have been decalcified are generally unsuccessful for FISH analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.

Supportive Data

Each probe was independently tested on a set of formalin-fixed, paraffin-embedded tissue specimens from patients diagnosed with a B-cell lymphoma and noncancerous lymph node specimen. Normal cutoff was calculated based on the results from 25 normal specimens. For each probe set a series of chromosomally abnormal specimens were evaluated to confirm each probe set detected the anomaly it was designed to detect.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

WHO Classification of Tumour of Haematopoietic and Lymphoid Tissues. Edited by SH Swerdlow, E Campo, NL Harris. IARC, Lyon 2008, pp 214-217, 220-226, 229-237, 262-278

Method Description Describes how the test is performed and provides a method-specific reference

Rearrangements involving CCND1/IGH, IGH/BCL2, MYC/IGH, BIRC3/MALT1, and IGH/MALT1 are detected using commercially available dual-color, dual-fusion (D-FISH) strategy probes. Rearrangements involving MYC and BCL6 are detected using commercially available dual-color break-apart probe (BAP) strategies. Rearrangements involving MYC/IGL are detected using a laboratory developed D-FISH strategy probe and rearrangements of IGL using a laboratory-developed BAP strategy. Formalin-fixed, paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the target areas on the hematoxylin and eosin (H and E)-stained slide is performed by a pathologist. Using the H and E-stained slide as a reference, target areas are etched with a diamond-tipped etcher on the back of the unstained slide to be assayed. The probe set is hybridized to the appropriate target areas and 2 technologists each analyze 100 interphase nuclei each (200 total) with the results expressed as a percent abnormal nuclei.(Unpublished Mayo method)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Samples processed Monday through Sunday. Results reported Monday through Friday 8am-5pm CST.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

4 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

7 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Indefinitely

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

B-Cell Lymphoma, FISH, Tissue

88271 x 2-DNA probe, each

88275-Interphase in situ hybridization, 100 to 300 cells

88291-Interpretation and report

 

One Additional FISH Probe

88271-DNA probe, each (if appropriate)

88275-Interphase in situ hybridization (if appropriate)

 

Two Additional FISH Probes

88271 x 2-DNA probe, each (if appropriate)

88275-Interphase in situ hybridization (if appropriate)

 

Three Additional FISH Probes

88271 x 3-DNA probe, each (if appropriate)

88275-Interphase in situ hybridization (if appropriate)

 

Four Additional FISH Probes

88271 x 4-DNA probe, each (if appropriate)

88275 x 2-Interphase in situ hybridization (if appropriate)

 

Five Additional FISH Probes

88271 x 5-DNA probe, each (if appropriate)

88275 x 2-Interphase in situ hybridization (if appropriate)

 

Six Additional FISH Probes

88271 x 6-DNA probe, each (if appropriate)

88275 x 3-Interphase in situ hybridization (if appropriate)

 

Seven Additional FISH Probes

88271 x 7-DNA probe, each (if appropriate)

88275 x 3-Interphase in situ hybridization (if appropriate)

 

Eight Additional FISH Probes

88271 x 8-DNA probe, each (if appropriate)

88275 x 4-Interphase in situ hybridization (if appropriate)

 

Nine Additional FISH Probes

88271 x 9-DNA probe, each (if appropriate)

88275 x 4-Interphase in situ hybridization (if appropriate)

 

Ten Additional FISH Probes

88271 x 10-DNA probe, each (if appropriate)

88275 x 5-Interphase in situ hybridization (if appropriate)

 

Eleven Additional FISH Probes

88271 x 11-DNA probe, each (if appropriate)

88275 x 5-Interphase in situ hybridization (if appropriate)

 

Twelve Additional FISH Probes

88271 x 12-DNA probe, each (if appropriate)

88275 x 6-Interphase in situ hybridization (if appropriate)

 

Thirteen Additional FISH Probes

88271 x 13-DNA probe, each (if appropriate)

88275 x 6-Interphase in situ hybridization (if appropriate)

 

Fourteen Additional FISH Probes

88271 x 14-DNA probe, each (if appropriate)

88275 x 7-Interphase in situ hybridization (if appropriate)

 

Fifteen Additional FISH Probes

88271 x 15-DNA probe, each (if appropriate)

88275 x 7-Interphase in situ hybridization (if appropriate)

 

Sixteen Additional FISH Probes

88271 x 16-DNA probe, each (if appropriate)

88275 x 8-Interphase in situ hybridization (if appropriate)

 

Seventeen Additional FISH Probes

88271 x 17-DNA probe, each (if appropriate)

88275 x 8-Interphase in situ hybridization (if appropriate)

 

Eighteen Additional FISH Probes

88271 x 18-DNA probe, each (if appropriate)

88275 x 9-Interphase in situ hybridization (if appropriate)

 

Nineteen Additional FISH Probes

88271 x 19-DNA probe, each (if appropriate)

88275 x 9-Interphase in situ hybridization (if appropriate)

 

Twenty Additional FISH Probes

88271 x 20-DNA probe, each (if appropriate)

88275 x 10-Interphase in situ hybridization (if appropriate)

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
19192Accession NumberN/A
19193Referring Pathologist/Physician46608-6
19194Ref Path/Phys AddressIn Process
19195Material:In Process
19196Specimen:31208-2
19197Microscopic Description:In Process
19198Special Studies:N/A
19199Final Diagnosis:34574-4
19200Comment:48767-8
19201Revision Description:In Process
19202Signing Pathologist:19139-5
19203Special Procedures:N/A
19204SP Signing Pathologist:N/A
19205*Previous Report Follows*N/A
19206Addendum:35265-8
19207Addendum Comment:22638-1
19208Addendum Pathologist:19139-5